Anda di halaman 1dari 29

NHS public health

functions agreement
2015-16
Service specification no.17
NHS Fetal Anomaly Screening Programme 18+020+6 week fetal anomaly scan

Classification: official

December 2014

Title:
NHS public health functions agreement 2015-16, Service specification no.17
NHS Fetal Anomaly Screening Programme 18+0-20+6 week fetal anomaly scan
Author:
PHD/ IH&PHD/ PHPSU/ 10100
Document Purpose:
Policy
Publication date:
December 2014
Target audience:
NHS England regional directors, NHS England area directors

Contact details:
Public health policy and strategy unit
phpsu@dh.gsi.gov.uk

You may re-use the text of this document (not including logos) free of charge in any format
or medium, under the terms of the Open Government Licence. To view this licence,
visit www.nationalarchives.gov.uk/doc/open-government-licence/
Crown copyright
Published to gov.uk, in PDF format only.
www.gov.uk/dh

NHS England Publications Gateway Reference 02590

Classification: official

NHS public health functions


agreement 2015-16
Service specification no.17
NHS Fetal Anomaly Screening Programme
18+0-20+6 week fetal anomaly scan
Prepared by Public Health England

Classification: official

Contents
Contents ..................................................................................................................................... 4
Service specification No.17 ........................................................................................................ 6
Section 1: Purpose of Screening Programme............................................................................. 7
1.1.

Purpose of the Specification .............................................................................. 7

1.2.

Aim .................................................................................................................... 8

1.3.

Objectives .......................................................................................................... 8

1.4.

Expected health outcomes ................................................................................ 9

1.5.

Principles ........................................................................................................... 9

1.6.

Equality .............................................................................................................. 9

Section 2: Scope of Screening Programme .............................................................................. 11


2.1.

Description of screening programme ............................................................... 11

2.2.

Care pathway................................................................................................... 12

2.3.

Failsafe Procedures ......................................................................................... 15

2.4.

Roles and accountability throughout the pathway............................................ 18

2.5.

Commissioning Arrangements ......................................................................... 18

2.6.

Links between screening programme and national programme centre expertise


19

Section 3: Delivery of Screening Programme ........................................................................... 20

3.1.

Service model summary .................................................................................. 20

3.2.

Programme Co-ordination ............................................................................... 20

3.3.

Clinical and corporate governance .................................................................. 20

3.4.

Definition, identification and invitation of cohort/eligibility ................................ 21

3.5.

Location(s) of programme delivery .................................................................. 21

3.6.

Days/Hours of operation .................................................................................. 21

3.7.

Entry into the screening programme ................................................................ 22

3.8.

Working across interfaces between departments and organisations ............... 22

3.9.

Information on Test/ Screening Programme .................................................... 23

3.10.

Testing (laboratory service, performance of test by individuals)................... 23

3.11.

Results giving, reporting and recording ........................................................ 23

3.12.

Transfer of and discharge from care obligations .......................................... 24

3.13.

Public Information ........................................................................................ 24

3.14.

Exclusion criteria .......................................................................................... 24

3.15.

Staffing ......................................................................................................... 24

3.16.

User involvement ......................................................................................... 25


Classification: official

NHS public health functions agreement 2015-16

3.17.

Premises and equipment ............................................................................. 25

3.18.

Safety & Safeguarding ................................................................................. 26

Section 4: Service Standards, Risks and Quality Assurance .................................................... 27


4.1.

Key criteria and standards ............................................................................... 27

4.2.

Risk assessment of the screening pathway ..................................................... 27

4.3.

Quality assurance ............................................................................................ 27

4.4.

Safety concerns, safety incidents and serious incidents .................................. 28

4.5.

Procedures and Protocols ............................................................................... 28

4.6.

Service improvement ....................................................................................... 28

Section 5: Data and Monitoring ................................................................................................ 29


5.1.

Key performance indicators ............................................................................. 29

5.2.

Data collection, monitoring and reporting ........................................................ 29

Classification: official

Service specification No.17


This is a service specification within Annex C of the NHS public
health functions agreement 2015-16 (the 2015-16 agreement)
published in December 2014.
This service specification is to be applied by NHS England in
accordance with the 2015-16 agreement. This service specification
is not intended to replicate, duplicate or supersede any other
legislative provisions that may apply.
Where a specification refers to any other published document or
standard, it refers to the document or standard as it existed at the
date when the 2015-16 agreement was made between the Secretary
of State and NHS England Board. Any changes in other published
documents or standards may have effect for the purposes of the
2015-16 agreement in accordance with the procedures described in
Chapter 3 of the 2015-16 agreement
Service specifications should be downloaded in order to ensure that
commissioners and providers refer to the latest document that is in
effect.
The 2015-16 agreement including all service specifications within
Annex C is available at www.gov.uk (search for commissioning
public health).

Classification: official

Section 1: Purpose of Screening


Programme
1.1.

Purpose of the Specification

To ensure a consistent and equitable approach across England a common national service
specification must be used to govern the provision and monitoring of fetal anomaly
ultrasound screening services as part of the Fetal Anomaly Screening Programme (FASP).
The purpose of the service specification is to outline the service and quality indicators
expected by NHS England for the population for whom it is responsible and which meets
the policies, recommendations and standards of the UK National Screening Committee (UK
NSC).
This specification is not designated to replicate, duplicate or supersede any relevant
legislative provisions which may apply, e.g. of the Health and Social Care Act 2008 or the
work undertaken by the Care Quality Commission. The specification will be reviewed and
amended in line with any new guidance as quickly as possible.
This specification should be read in conjunction with:

current FASP guidance www.fetalanomaly.screening.nhs.uk.

National Ultrasound Guidance and Standards: 18+0-20+6 week fetal anomaly


scan at: http://fetalanomaly.screening.nhs.uk/standardsandpolicies

FASP Ultrasound Practitioners


Handbook http://www.fetalanomaly.screening.nhs.uk/combinedscreeningresou
rces

FASP Laboratory Handbook www.fetalanomaly.screening.nhs.uk

any separate service specifications for the screening laboratory used by the
provider for antenatal screening services

UK NSC Guidance, Managing Serious Incidents in the English NHS National


Screening Programmes http://www.screening.nhs.uk/incidents

Failsafe Processes www.screening.nhs.uk/failsafe

Guidance & updates on Key Performance Indicators can be found


at http://www.screening.nhs.uk/kpi
Classification: official

Section 1: Purpose of Screening Programme

1.2.

Antenatal Screening Working Standards: National Downs Syndrome


Screening Programme for England (2007)

UK NSC Guidance, Managing Serious Incidents in the English NHS National


Screening Programmes http://www.screening.nhs.uk/quality-assurance

Antenatal Screening Working Standards: National Downs Syndrome


Screening Programme for England (2007)

National Institute for Health and Clinical Excellence (NICE) Clinical guideline 62
Antenatal care June 2010 http://www.nice.org.uk/guidance/CG62

National Institute for Health and Clinical Excellence (NICE) Clinical guideline
CG 129 Antenatal care September
2011 http://www.nice.org.uk/guidance/CG129

Royal College of Radiologists. Standards for Ultrasound Equipment

https://www.rcr.ac.uk/docs/radiology/pdf/StandardsforUltrasoundEquipmentJan
2005.pdf

Service specification No17, fetal Anomaly Screening

http://www.gov.uk/government/publications/public-health-commissioning-in-thenhs-2015-to-2016

Maternity Pathway Payments: Who pays for


what http://www.england.nhs.uk/wp-content/uploads/2014/01/who-pays-forwhat-fin.pdf

Aim

The NHS Fetal Anomaly Screening Programme aims to ensure that there is equal access
to uniform and quality-assured screening across England and that eligible women are
provided with high quality information, so that they can make an informed choice about their
screening options and pregnancy.

1.3.

Objectives

The objectives of the 18+0 to 20+6 weeks ultrasound scan are to:

offer screening to eligible women in England to identify abnormalities


incompatible with life

identify abnormalities which may benefit from antenatal treatment

identify abnormalities which require early intervention following delivery

Classification: official

NHS public health functions agreement 2015-16

1.4.

to facilitate choice in appropriate diagnostic testing and pregnancy


management

Expected health outcomes

The following are expected in accordance to the programmes overall aims and objectives:

1.5.

1.6.

women are able to make informed and supported decisions about how they
respond to the identification of a fetal anomaly within the screening programme

diagnostic and follow on care services are easily accessible and support a
womans decision

Principles

all individuals will be treated with courtesy, respect and an understanding of


their needs

all those participating in the Fetal Anomaly screening programme will have
adequate information on the benefits and risks to allow an informed decision to
be made before participating

the target population will have equitable access to screening

screening will be effectively integrated across a pathway with clear lines of


communication between including between the different providers, screening
centres, primary care and secondary care

Equality

The provider will be able to demonstrate what systems are in place to ensure equity of
access to screening and subsequent diagnostic testing. This will include, for example, how
the services are designed to ensure that there are no obstacles to access on the grounds of
race, culture, sexual preference, physical or learning disabilities.
The provider will have procedures in place to identify and support those women who are
considered vulnerable/ hard-to-reach, including but not exclusive to, those who are not
registered with a GP; asylum seekers; women in prison; women with drug or alcohol harm
issues; women with learning disabilities; women experiencing domestic abuse, with
physical disabilities or women with communications difficulties. The provider will comply
with safeguarding policies and good practice recommendations for such women.

Classification: official

Section 1: Purpose of Screening Programme

Screening will be effectively integrated across a pathway with clear lines of communication
between the different providers, screening centres, primary care and secondary care.
Providers are expected to meet the public sector Equality Duty which means that public
bodies have to consider all individuals when carrying out their day-to-day work in shaping
policy, in delivering services and in relation to their own
employees. https://www.gov.uk/equality-act-2010-guidance
It also requires that public bodies:

have due regard to the need to eliminate discrimination

advance equality of opportunity

foster good relations between different people when carrying out their activities

Classification: official

10

NHS public health functions agreement 2015-16

Section 2: Scope of Screening Programme


2.1.

Description of screening programme

The Fetal Anomaly screening Programme recommend a mid-pregnancy scan which is


undertaken between 18+0 to 20+6 weeks of pregnancy to screen for major fetal anomalies.
The examination should be undertaken in accordance with the requirements of the FASP
guidance (Anatomical Base Menu and Fetal Cardiac Protocol
(www.fetalanomaly.screening.nhs.uk/standards)
The first scan is an early pregnancy scan performed from 8+0 weeks gestation and is used
mainly for dating the pregnancy and confirming viability. The second scan is undertaken
between 18+0 to 20+6 weeks of pregnancy and screens for major structural abnormalities.
The 11 auditable conditions currently screened for are:

Anencephaly;

Open spina bifida;

Cleft lip;

Diaphragmatic hernia;

Gastroschisis;

Exomphalos;

Serious cardiac abnormalities;

Bilateral renal agenesis;

Lethal skeletal dysplasia;

Edwards syndrome (Trisomy 13)

Pataus syndrome (Trisomy 18)

The ultrasound scan appointment should incorporate pre-scan counselling, the ultrasound
examination, post-scan counselling and reporting. The time allocation for appointments to
meet these requirements for a singleton pregnancy is a minimum of thirty (30) minutes and
for a multiple pregnancy is forty five (45) minutes.
In delivering a national screening programme and to ensure national consistency the local
provider is expected to fulfil the following, in conjunction with guidance from the National
Programme where appropriate and as detailed in the standard and policies available
on www.fetalanomaly.screening.nhs.uk/standards
Classification: official

11

Section 2: Scope of Screening Programme

2.2.

work to nationally agreed common standards and policies

be required to implement and support national IT developments

use materials provided by the national screening programme, e.g. leaflets,


training media and protocols for their use

be required to respond to national action/lessons such as change of software,


equipment supplier, techniques

work with NHS England in reporting on and resolving serious incidents

provide data and reports against programme standards, key performance


indicators (KPIs), and quality indicators as required by the national screening
programme on behalf of the UK NSC

take part in quality assurance processes and implement changes


recommended by QA including urgent suspension of services if required

implement and monitor failsafe procedures and continuously ensure quality

work with bordering providers to ensure that handover of results or patients is


smooth and robust

participate in evaluation of the screening programme

ensure all health care professionals access appropriate training to maintain


continuous professional development and competency

ensure appropriate governance structures are in place

Care pathway

A description of the fetal anomaly screening pathway is given below, along with a diagram
of the pathways showing failsafe processes (Figure 1)
A full description of the screening pathway can be found on the Map of Medicine
at: www.mapofmedicine.com
The fetal anomaly screening pathway consists of the following:

the eligible population is identified through maternity antenatal care services.


For fetal anomaly screening the eligible population are women <23+0 weeks of
pregnancy confirmed by ultrasound scan

during the first contact or booking visit with the midwife, verbal and written
information will be given about the fetal anomaly scan is given to the woman
(using UK NSC booklet Screening Tests for You and Your Baby) to enable her
to make an informed choice and screening offered

Classification: official

12

NHS public health functions agreement 2015-16

the offer of fetal anomaly screening and subsequent acceptance or decline


should be documented in the womans health records/IT system

the fetal anomaly ultrasound scan should be performed between 18+0-20+6


weeks gestation. Where the image quality of the first scan is compromised a
single further scan should be offered by 23+0 weeks gestation

The fetal anomaly ultrasound scan should be performed to comply with the
requirements of the fetal anatomical survey and fetal cardiac protocol which
are detailed in the programme standards
at: www.fetalanomaly.screening.nhs.uk/standards, Note: an additional view ( 3
Vessel & trachea view) has been added to the Fetal Cardiac Protocol and plans
to commence training of sonographers and introduction of the viewing and
reporting of this view should be developed and commenced during 2015/16
with the aim for full compliance by Mid-2016.

a local protocol must be in place to ensure that all women who accept fetal
anomaly screening complete the testing pathway

Management of results:
No anomaly suspected: all women should be notified of their scan findings at the time of
the screen. The results should be documented in the health record/IT system.
Anomaly suspected: the woman is informed at the time of the scan the
sonographer/midwife/clinician and mother discuss the options available
1. to have no further investigations
2. accept referral for a further scan/investigation i.e. to a second
sonographer/obstetrician/fetal medicine department as per local protocol. The
result should be recorded in the health record/IT system
Discussion should include sufficient information to ensure that the woman is aware of the
purpose, benefits, limitations and implications of undergoing further investigations.

if further investigation is declined the woman continues with her pregnancy and
the pregnancy outcome is obtained for audit purposes. A mechanism should be
in place to alert the practitioners providing subsequent care (including the
newborn physical examination).

Following further scan/ investigation there are the following possible outcomes:

No anomaly identified: all women should be notified of their scan findings at


the time of the screen. The results should be documented in the health
record/IT system and the pregnancy outcome obtained.

Classification: official

13

Section 2: Scope of Screening Programme

Anomaly suspected/identified: the woman is informed at the time of the


scan. The sonographer/midwife/clinician and mother discuss the findings and
the two options available
o Declines further management: Decision is recorded in the health record. The
woman continues with pregnancy and outcome is obtained. A mechanism
should be in place to alert the practitioners providing subsequent care
(including the newborn physical examination).
o Accepts referral to either an in-house consultant with fetal anomaly/ultrasound
experience or a fetal medicine unit (FMU) depending on the condition
suspected and local protocol

Diagnostic Testing
Some fetal anomalies will be confirmed by scan alone others will require prenatal diagnostic
testing.

Where prenatal diagnostic testing (PND) is required discussion should


include sufficient information to ensure that the woman is aware of the purpose,
benefits, limitations and implications of undergoing a diagnostic test
o consent is obtained and the womans decision is documented in the health
care records
o the woman is given information on how the results of PND may be
communicated to her and a method agreed
o PND is performed in accordance with RCOG and NICE Guidelines (insert ref).
Note: PND for a Multiple Pregnancy should be conducted at a tertiary Fetal
Medicine Unit due to the specialised nature of the procedures and the
increased risk of miscarriage.
o where the indication for undertaking PND is a suspected fetal anomaly the
sample is sent to the cytogenetic laboratory for full karyotype
o local protocols should be in place between the laboratory and maternity
service to log receipt of a fit for purpose sample, deal with incomplete
information on the request form, or any unacceptable samples that require
repeat specimens. This should be done as soon as practicable to ensure
timely processing of samples and all requests should be tracked until
completed
o Normal PND result: the woman will continue with pregnancy and outcome is
obtained.

following diagnosis of a fetal anomaly (either by ultrasound or PND),


information should be shared between the specialist teams, maternity services
and primary care to ensure appropriate pregnancy management/delivery of the
baby and monitoring of screening outcomes

local protocols should be in place to ensure multi-disciplinary links and close


working relationships between maternity services and specialist services are
established and function well

Classification: official

14

NHS public health functions agreement 2015-16

Confirmation of fetal anomaly:

the woman is given the opportunity to discuss the results with health
professionals who are knowledgeable about the identified fetal anomaly. This
will include the offer of a termination or continuing support through pregnancy

if the woman chooses not to undergo termination and continues with her
pregnancy a referral to appropriate paediatric and support services should be
made

a pregnancy outcome should be recorded and a mechanism should be in place


to alert the practitioners providing subsequent care (including the newborn
physical examination)

if termination of pregnancy is accepted, this should be undertaken in line with


the Abortion Act 1967 and RCOG guidance

A local protocol should be in place for reporting and appropriate referral of any babies born
with a suspected/confirmed fetal anomaly who were not identified in the antenatal period, to
allow review of the womans participation in the screening pathway.
All providers are expected to review and risk assess local pathways in the light of national
FASP programme guidance and work with the Quality Assurance teams, and NHS England
Screening and Immunisation Leads and Teams to develop, implement and maintain
appropriate risk reduction measures. This should involve mechanisms to audit
implementation, report incidents, ensure staff training and development and competencies,
and have appropriate links with internal governance arrangements.
A full description of the screening pathway can be found on the map of medicine
at http://healthguides.mapofmedicine.com
A pathway for Fetal Anomaly screening with identification of failsafe points is shown in
figure 1 in section 2.3 below.

2.3.

Failsafe Procedures

Quality assurance within the screening pathway is managed by including failsafe


processes. Failsafe is a back-up mechanism, in addition to usual care, which ensures if
something goes wrong in the screening pathway, processes are in place to identify (i) what
is going wrong and (ii) what action follows to ensure a safe outcome.

Classification: official

15

Section 2: Scope of Screening Programme

The provider is expected to:

have and evidence appropriate failsafe mechanisms in place across the whole
screening pathway

review and risk assess local screening pathways in the light of guidance offered
by Quality Assurance processes or the National Screening programme

work with NHS England and Quality Assurance Teams to develop, implement,
and maintain appropriate risk reduction measures

ensure that mechanisms are in place to regularly audit implementation of risk


reduction measures and report incidents

ensure that appropriate links are made with internal governance arrangements,
such as risk registers

ensure staff have access to appropriate training and development to maintain


competencies

A Map of Medicine screening pathway for the 18+0-20+6 week fetal anomaly scan with
failsafe points is available on the Map of Medicine website and in Figure 1 below.

Classification: official

16

NHS public health functions agreement 2015-16

Figure 1 Map of Medicine screening pathway with failsafe points

Classification: official

17

Section 2: Scope of Screening Programme

2.4.

Roles and accountability throughout the pathway

The FASP programme is dependent on systematic specified relationships between


stakeholders. Stakeholders include maternity services, obstetric ultrasound services, the
diagnostic laboratories, fetal medicine and specialist services, primary care/GPs and
professional bodies who set guidance for maternal and fetal medicine and management of
care in pregnancy.
NHS England will be expected to ensure that the whole pathway is robust.
The provider will be expected to fully contribute to ensuring that systems are in place to
maintain the quality of the whole screening pathway in their organisation. This will include,
but is not limited to:

provision of robust screening coordination which links with all elements of the
screening pathway

ensuring that community midwifery services are supported to facilitate early


booking for maternity care agreeing and documenting roles and responsibilities
relating to all elements of the screening pathway across organisations and
organisational boundaries

developing joint audit and monitoring processes

agreeing joint failsafe mechanisms where required to ensure safe and timely
processes across the whole screening pathway

contributing to any NHS England and public health screening lead initiatives in
screening pathway development in line with UK NSC expectations

providing or seeking to provide robust electronic links with relevant


organisations

links with primary care

the need for robust IT systems across the screening pathway

For further specific staffing requirements refer to section 3.15.

2.5.

Commissioning Arrangements

Fetal anomaly screening services will be commissioned by NHS England alongside


specialised services where appropriate. Commissioning the fetal anomaly screening
pathway involves commissioning at different levels which may include Area Teams, CCGs,
and directly by maternity services. Refer to Maternity Pathway Payments: Who pays for
what See section 1.1.

Classification: official

18

NHS public health functions agreement 2015-16

2.6.

Links between screening programme and national programme centre expertise

PHE, through the national screening programmes, is responsible for defining high-quality,
uniform screening, providing accessible information to both the public and health care
professionals, and developing and monitoring standards. It is also responsible for the
delivery of national quality assurance, based at regional level, and for ensuring training and
education for all those providing screening is developed, commissioned and delivered
through appropriate partner organisations.
PHE will be responsible for delivery of the essential elements of screening programmes
best done once at national level.
These include setting clear specifications for equipment, IT and data.

Classification: official

19

Section 3: Delivery of Screening Programme

Section 3: Delivery of Screening


Programme
3.1.

Service model summary

The model of delivery for the screening programme is primarily through maternity services
care.
See section 2.2 Care Pathway above for further details.

3.2.

Programme Co-ordination

The provider will be responsible for ensuring that the part of the programme they deliver is
coordinated and interfaces seamlessly with other parts of the programme with which they
collaborate, in relation to timeliness and data sharing.
The provider will ensure there are one or more named individuals responsible for the
coordination of the delivery and planning of the programme aided by appropriate
administrative support to ensure timely reporting and response to requests for information.
Where there is only one named coordinator, the provider will ensure that there are
adequate cover arrangements in place to ensure sustainability and consistency of
programme.
The provider and NHS England will meet at regular intervals (at least annually) to monitor
and review the local screening pathway. The meetings will include representatives from
programme coordination, clinical services, laboratory services and service management.

3.3.

Clinical and corporate governance

The providers will:

ensure co-operation with and representation on the local screening oversight


arrangements/ structures e.g. screening programme boards/groups

ensure that responsibility for the screening programme lies at Director-level

ensure that there is appropriate internal clinical oversight of the programme and
have its own management and internal governance of the services provided

Classification: official

20

NHS public health functions agreement 2015-16

with the designation of a Clinical Lead, a programme coordinator/manager


and the establishment of a multidisciplinary steering group/programme board
including NHS England representation (that meets quarterly) as a minimum
and has terms of reference and record of meetings

ensure that there is regular monitoring and audit of the screening programme,
and that, as part of organisations Clinical Governance arrangements, the
organisations Board is assured of the quality of the screening programme

comply with the UK NSC guidance Managing Serious Incidents

have appropriate and timely arrangements in place for referral into treatment
services that meet programme standards found on the FASP website

be able to provide documented evidence of clinical governance and


effectiveness arrangements on request

ensure that an annual report of screening services is produced which is signed


off by the organisations Board

have a sound governance framework in place covering the following areas:


-

3.4.

information governance/records management


equality and diversity
user involvement, experience and complaints
failsafe procedures
Risks and Mitigation plans

Definition, identification and invitation of cohort/eligibility

The target screening population is all pregnant women up to 23+0 confirmed weeks of
pregnancy.

3.5.

Location(s) of programme delivery

The provider will ensure accessible service provision for the specified population while
assuring that all locations where fetal anomaly screening occurs fully comply with the
policies, standards and guidelines referenced in this service specification.

3.6.

Days/Hours of operation

The days and hours of operation are to be determined locally and must ensure sufficient
resources are in place to meet screening demand within required timescales without
compromising relevant standards and guidelines. However, timeliness is essential and is a
key criteria of quality along all parts of the screening pathway.
Classification: official

21

Section 3: Delivery of Screening Programme

3.7.

Entry into the screening programme

All women will be identified through maternity services. While there is nothing specific in the
general practitioner (GP) contract regarding the Fetal Anomaly screening programme, GPs
have a key role in ensuring that pregnant women presenting to them are referred on as
soon as possible to midwifery services.
Providers will ensure timely access for women to all aspects of the screening programme.

3.8.

Working across interfaces between departments and organisations

The screening programme is dependent on strong functioning working relationships (both


formal and informal) between primary care, the hospital trust (maternity and obstetric
ultrasound services), the screening laboratory, fetal medicine, cytogenetic services,
paediatrics and other appropriate clinical services.
Accurate and timely communication and handover across these interfaces is essential to
reduce the potential for errors and ensure a seamless pathway for service users. It is
essential that there remains clear named clinical responsibility at all times and at handover
of care the clinical responsibility is clarified.
The Provider will be expected to fully contribute to ensuring that cross organisational
systems are in place to maintain the quality of the entire screening pathway. This will
include, but is not limited to:

work to nationally agreed programme standards, policies and guidance

ensure that midwives and obstetric sonographers are supported to facilitate


early booking for maternity care within primary and community care settings

provide strong clinical leadership and clear lines of accountability

agree and documenting roles and responsibilities relating to all elements of the
screening pathway across organisations to assure appropriate handover
arrangements are in place between services

develop joint audit and monitoring processes

agree jointly on what the failsafe mechanisms are required to ensure safe and
timely processes across the whole screening pathway

develop an escalation process for Serious screening Incidents (SIs)

contribute to any NHS Englands initiatives in screening pathway development


in line with UKNSC expectations

Classification: official

22

NHS public health functions agreement 2015-16

3.9.

facilitate, provide or support education and training both inside and outside the
provider organisation

Information on Test/ Screening Programme

Prior to any screening offer, the midwife/sonographer will provide verbal and written
information regarding screening utilising the approved UK NSC resources as a guide for
discussion. Where there are specific communication requirements (e.g. English is not the
womans first language, visual/hearing impairment) appropriate interpretation services
should be used during the booking appointment and appropriate information provided. All
women, including those with special requirements, will be fully informed of the choices
regarding all antenatal screening programmes.
The information should be impartially presented and should include an explanation of the
limitations of the screening test. The decision to consent to screening or to decline should
be recorded appropriately by the midwife at booking and confirmed by the sonographer
prior to the fetal anomaly scan being undertaken.

3.10. Testing (laboratory service, performance of test by individuals)


Providers will ensure that the fetal anomaly ultrasound scan is performed by a health
professional with at least one of the qualifications outlined in Section 3.15.
All diagnostic ultrasound procedures should be undertaken according to RCOG and NICE
guidance by health professionals who are trained to undertake these procedures under
continuous direct ultrasound guidance and are competent in the safe use of ultrasound
equipment.
Diagnostic procedures for women with a multiple pregnancy must be undertaken at a
tertiary Fetal Medicine Unit.
Cytogenetic laboratories performing analysis of prenatal samples should be CPA accredited
and participate in an external Quality assurance scheme (i.e. NEQAS).

3.11. Results giving, reporting and recording


Screening results should be explained to women at the time of the scan by appropriately
trained staff and recorded in the womans health record/IT system.
See section 2.2 for further detail.
Classification: official

23

Section 3: Delivery of Screening Programme

3.12. Transfer of and discharge from care obligations


Active inclusion in the screening programme ends when:

no fetal anomaly is identified

a fetal anomaly is confirmed and the woman has been provided with
information on her further options

3.13. Public Information


Providers must always use the nationally-developed public information leaflets at all stages
of the screening pathway to ensure accurate messages about the risks and benefits of
screening and any subsequent surveillance or treatment are provided and should involve
the national screening team before developing any other materials.
Providers must involve the national screening team in the development of local publicity
campaigns to ensure accurate and consistent messaging, particularly around informed
choice, and to access nationally-developed resources.

3.14. Exclusion criteria


Women presenting for maternity care at >23+0 weeks gestation.

3.15. Staffing
The provider will have in place a dedicated screening coordinator/screening midwife and a
lead screening sonographer (with appropriate deputy arrangements to ensure continual
cover), to oversee the implementation, delivery and monitoring of the screening programme
in both the antenatal and ultrasound settings. These staff are also responsible for ensuring
that there is an on -going educational programme for health professionals involved in
screening.
Providers are responsible for funding minimum training requirements to maintain an
effective screening workforce including CPD where necessary. Training standards are
detailed at http://fetalanomaly.screening.nhs.uk/training
The provider will ensure that there are adequate numbers of appropriately trained staff in
place to deliver the screening programme in line with best practice guidelines.

Classification: official

24

NHS public health functions agreement 2015-16

All professionals involved in the provision of ultrasound screening for fetal anomaly
screening should comply with the training requirements detailed in the FASP Ultrasound
Practitioners handbook
(http://www.fetalanomaly.screening.nhs.uk/combinedscreeningresources)
The NHS FASP recommends that any person undertaking an ultrasound scan on pregnant
women, for the purpose of screening and diagnosis of a related condition should hold, as a
minimum, one of the following:

Certificate/Diploma (as appropriate) in Medical Ultrasound (CMU/DMU) of the


College of Radiographers (CoR) with evidence of appropriate continuous
professional development (CPD).

Post Graduate Certificate in Medical Ultrasound (PgCert) approved and


validated by a Higher Institute of education and accredited by the Consortium
for Sonographic Education (CASE or equivalent).The qualification will be
relevant to obstetric ultrasound practice.

Royal College of Obstetricians and Gynaecologists (RCOG) Royal College of


Radiologists (RCR) Diploma in Obstetric Ultrasound or the Advanced Skills
Training Module.

3.16. User involvement


The provider(s) will be expected to:

demonstrate that they regularly seek out the views of service users, families
and others in respect of planning, implementing and delivering services

demonstrate how those views will influence service delivery for the purposes of
raising standards

make results of any user surveys/questionnaires available to NHS England on


request

3.17. Premises and equipment


The provider will:

ensure that suitable premises and equipment are provided for the screening
programme

Classification: official

25

Section 3: Delivery of Screening Programme

have appropriate polices in place for equipment calibration and electronic


safety checks, maintenance, repair and replacement in accordance with
manufacturer specification to ensure programme sustainability

ensure that ultrasound scanning equipment meets the European Council


Directive, enforced by the Medicines and Healthcare Regulatory Agency, to
ensure that it is safe and effective to use

ensure that ultrasound equipment should be capable of producing and storing


images of appropriate diagnostic quality

Royal College of Radiologists. Standards for Ultrasound


Equipment. https://www.rcr.ac.uk/docs/radiology/pdf/StandardsforUltrasoundEq
uipmentJan2005.pdf

3.18. Safety & Safeguarding


The provider should refer to and comply with the safety and safeguarding requirements as
set out in the NHS Standard Contract. As an example, please see link below for 2013/14
NHS Standard Contract: http://www.england.nhs.uk/nhs-standard-contract

Classification: official

26

NHS public health functions agreement 2015-16

Section 4: Service Standards, Risks and


Quality Assurance
4.1.

Key criteria and standards

Programme standards are available on the programme


website www.fetalanomaly.screening.nhs.uk/standards
Providers will meet the acceptable and work towards the achievable programme standards.
A number of resources to support providers are available on the programme website.

4.2.

Risk assessment of the screening pathway

Providers are expected to have an internal quality assurance and risk management process
that assures the commissioners of its ability to manage the risks of running a screening
programme.
Providers will:

ensure that mechanisms are in place to regularly audit implementation of risk


reduction measures and report incidents

ensure that risks are reported through internal governance arrangements, such
as risk registers

review and risk assess local screening pathways in the light of guidance offered
by Quality Assurance processes or the National Screening programme

work with the Commissioner and Quality Assurance Teams to develop,


implement, and maintain appropriate risk reduction measures

High scoring risks will be identified and agreed between the provider and the
commissioners and plans put in place to mitigate against them.

4.3.

Quality assurance

Providers will participate fully in national Quality Assurance processes, co-operate in


undertaking ad-hoc audits and reviews as requested by QA teams and respond in a timely

Classification: official

27

Section 4: Service Standards, Risks and Quality Assurance

manner to their recommendations. This will include the submission to QA teams and
commissioners of:

Agreed data and reports from external quality assurance schemes

minimum data sets as required

self-assessment questionnaires / tools and associated evidence

All providers should operate failsafe systems that can identify, as early as possible, women
and babies that may have been missed or where screening results are incomplete.
Providers will respond to QA recommendations within agreed timescales. They will produce
with agreement of commissioners of the service an action plan to address areas for
improvement that have been identified in recommendations. Where QA believe there is a
significant risk of harm to the population, they can recommend to commissioners to
suspend a service.

4.4.

Safety concerns, safety incidents and serious incidents

Providers will comply with the national guidance for the management of safety concerns
and incidents in screening programmes and NHS England guidance for the management of
serious incidents (http://www.screening.nhs.uk/incidents)

4.5.

Procedures and Protocols

The provider will be able to demonstrate that they have audited procedures, policies and
protocols in place to ensure best practice is consistently applied for all elements of the
screening programme.

4.6.

Service improvement

Where national recommendations and acceptable/achievable standards are not currently


fully implemented the provider will be expected to indicate in service plans what changes
and improvements will be made over the course of the contract period.
The provider shall develop a CSIP (continual service improvement plan) in line with the
KPIs and the results of internal and external quality assurance checks. The CSIP will
respond and any performance issues highlighted by the commissioners, having regard to
any concerns raised via any service user feedback. The CSIP will contain action plans with
defined timescales and responsibilities, and will be agreed with the commissioners.

Classification: official

28

NHS public health functions agreement 2015-16

Section 5: Data and Monitoring


5.1.

Key performance indicators

The provider shall adhere to the requirements specified in the document Key Performance
Indicators for Screening. Please refer to http://www.screening.nhs.uk/kpi for further details,
guidance and updates on these indicators.

5.2.

Data collection, monitoring and reporting

Providers should:

ensure that appropriate systems are in place to support programme delivery


including audit and monitoring functions

continually monitor and collect data regarding its delivery of the Service

comply with the timely data requirements of the National Screening programme
and regional Quality Assurance teams. This will include the production of
annual reports. The current dataset can be accessed from the National
Screening programme website.

For quality and monitoring, information should be shared with the National Congenital
Anomaly and Rare Disease Registration Service.

Classification: official

29